| CTRI Number |
CTRI/2025/09/095494 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of Erandmooladi Basti and Punarnavadi Basti in Trikgrah(Ankylosing Spondylitis) in 50 participants. |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of Erandmooladi Basti And Punarnavadi Basti in Trikgrah(Ankylosing Spondylitis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Sharma |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand |
| Address |
Patanjali Ayurveda Hospital
Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand 249405 India, Panchakarma Department OPD No.4, 23.
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee road Haridwar Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9878765720 |
| Fax |
|
| Email |
ssakshi9625@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Shivani Mahajan |
| Designation |
Proffessor |
| Affiliation |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand |
| Address |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand 249405 India, Panchakarma Department OPD No.4
Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand UTTARANCHAL249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9760376761 |
| Fax |
|
| Email |
Shivani.mahajan@divyayoga.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakshi Sharma |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand |
| Address |
Patanjali Ayurveda Hospital,Patanjali Yogpeeth Phase 1 ,Haridwar Uttarakhand 249405 India, Panchakarma Department, OPD No.4, 23
Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand UTTARANCHAL249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9878765720 |
| Fax |
|
| Email |
ssakshi9625@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee road Haridwar Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar |
| Address |
Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee road Haridwar Uttarakhand |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sakshi |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Haridwar,Uttarakhand |
Patanjali Yogpeeth Phase 1 Haridwar Uttarakhand ,249405 India Panchakarma Department Opd No. 4,23.
Hardwar
UTTARANCHAL |
9878765720
ssakshi9625@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M457||Ankylosing spondylitis of lumbosacral region. Ayurveda Condition: TRIKAGRAHAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Anuvasana basti-Bhaishajya Ratnavali5/1286-1287,Punarnavadi Niruha basti-Charak Samhita Siddhisthan 3/65-68, Procedure details: (Procedure Reference: Anuvasana basti-Bhaishajya Ratnavali5/1286-1287,Punarnavadi Niruha basti-Charak Samhita Siddhisthan 3/65-68, Procedure details: Procedure details: Procedure Punarnavadi Niruha basti reference:Charak Samhita Sidhhisthan 3/38-42.Basti will be administered alternately in Yoga basti schedule,Reference-Ashtanga Hridayam Sutrasthan 19/64.Anuvasana Basti:POORVA KARMA-Patient will be given Abhyanga & Swedan followed with warm water bath & then patient will be advised to take food less by ¼ of the usual quantity him to eliminate feaces, urine or flatus if present.PASCHAT KARMA-Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight & relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus & enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Anuvasana Basti will be administered with Murchhita til taila(Reference-Anuvasana basti-Bhaishajya Ratnavali5/1286-1287), .PASCHAT KARMA-Buttocks of the patient will be patted with palms for 3 times & will be advised to relax in supine position. Patient will be advised to empty his bowel after getting urge for defecation. Niruha Basti:POORVA KARMA-After passing feaces, urine & flatus, the patient on empty stomach should be prepared with Abhyanga & Swedan. However, patient should not be hungry.PRADHAN KARMA-Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight & relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus & enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered.PASCHAT KARMA-Patient will be advised to lie on his back i.e in supine position comfortably on the bed. Patient will be advised to empty his bowel after getting urge for defecation. Duration: Basti will be administered for 8 days. Follow up will be of 30 days.)
| | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Anuvasana basti-Bhaishajya Ratnavali5/1286-1287,Erandmooladi Niruha basti-Charak Samhita Siddhisthan 3/38-42, Procedure details: Procedure details: Procedure Erandmooladi Niruha basti reference:Charak Samhita Sidhhisthan 3/38-42.Basti will be administered alternately in Yoga basti schedule,Reference-Ashtanga Hridayam Sutrasthan 19/64.Anuvasana Basti:POORVA KARMA-Patient will be given Abhyanga & Swedan followed with warm water bath & then patient will be advised to take food less by ¼ of the usual quantity him to eliminate feaces, urine or flatus if present.PASCHAT KARMA-Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight & relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus & enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Anuvasana Basti will be administered with Murchhita til taila(Reference-Anuvasana basti-Bhaishajya Ratnavali5/1286-1287), .PASCHAT KARMA-Buttocks of the patient will be patted with palms for 3 times & will be advised to relax in supine position. Patient will be advised to empty his bowel after getting urge for defecation. Niruha Basti:POORVA KARMA-After passing feaces, urine & flatus, the patient on empty stomach should be prepared with Abhyanga & Swedan. However, patient should not be hungry.PRADHAN KARMA-Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form of pillow while keeping the body straight & relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus & enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered.PASCHAT KARMA-Patient will be advised to lie on his back i.e in supine position comfortably on the bed. Patient will be advised to empty his bowel after getting urge for defecation. Duration: Basti will be administered for 8 days. Follow up will be of 30 days.)
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18- 60 years
2.Either sex
3.Patients with classical features of Trikgrah.
4.Diagnosed case of Ankylosing spondylitis (AS).
5.Patients fit for Basti.
|
|
| ExclusionCriteria |
| Details |
1.Sciatica
2.Pregnancy & lactating mothers.
3.Congenital Deformity
4.Patients who are unfit for Basti karma.
5.Diagnosed case of any major systemic disorder like Chronic Renal Failure, Liver Cirrhosis, Uncontrolled Hypertension, Uncontrolled Diabetes Mellitus, Coronary Artery Disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters that will be assessed
1.Sandhi Shool (Pain in axial skeleton and peripheral joints)
2.Sandhi Jadyata (Stiffness)3
3.Angamard (Fatigue)
4.Quality of Sleep |
8,30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.ESR
2.CRP
3.BASMI (Bath Ankylosing Spondylitis Metrology Index)
|
8,30 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
11/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Comparative Clinical Evaluation of Erandmooladi Basti and Punarnavadi Basti in Trikgrah (Ankylosing Spondylitis) This will be conducted on 50 randomly selected patients from Opd/Ipd of Panchakarma department of Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar. Patient will be divided into 2 groups- 25 patients will be administered with Erandmooladi Basti and 25 patients will be administered with Punarnavadi Basti. Follow up will be taken after 1 month assessment to be done on the basis of subjective and objective parameters as discussed earlier. |